| CTRI Number |
CTRI/2024/06/068534 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
26/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare and evaluate the use of Ozonated water and Ozonated Olive oil in Chronic Periodontitis Patients as an adjunct to non surgical management. |
|
Scientific Title of Study
|
Evaluation and comparison of Ozonated water and Ozonated Olive oil as an adjunct to non surgical periodontal therapy: A Randomized Controlled Clinical Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sakshi Kotecha |
| Designation |
Postgraduate Student |
| Affiliation |
Sharad Pawar Dental College |
| Address |
Department of Periodontology and implant dentistry,Sharad Pawar Dental College, Datta Meghe Institue of Higher Education and Research (DMIHER(DU)), Sawangi (Meghe), Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9075340044 |
| Fax |
|
| Email |
drsakshikotecha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Jaiswal |
| Designation |
Professor |
| Affiliation |
Sharad Pawar Dental College |
| Address |
Department of Periodontology and implant dentistry,Sharad Pawar Dental College, Datta Meghe Institue of Higher Education and Research (DMIHER(DU)), Sawangi (Meghe), Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9960713010 |
| Fax |
|
| Email |
priyanka.banode@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sakshi Kotecha |
| Designation |
Postgraduate Student |
| Affiliation |
Sharad Pawar Dental College |
| Address |
Department of Periodontology and implant dentistry,Sharad Pawar Dental College, Datta Meghe Institue of Higher Education and Research (DMIHER(DU)), Sawangi (Meghe), Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9075340044 |
| Fax |
|
| Email |
drsakshikotecha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sharad Pawar Dental College |
| Address |
Datta Meghe Institue of Higher Education and Research (DMIHER(DU)) |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sakshi Kotecha |
Sharad Pawar Dental College |
Department of Periodontics & Implantology, SharadPawar Dental College, Sawangi, Wardha
Wardha
MAHARASHTRA |
9075340044
drsakshikotecha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ozonated olive oil |
All sites with probing depth greater than or equal to 4mm will be isolated carefully with cotton rolls and thoroughly dried and ozonated olive oil will be applied carefully subgingivally with the help of a disposable 2ml plastic syringe and a 28-gauge needle. |
| Intervention |
Ozonated water |
All sites with probing depth greater than or equal to 4mm will be isolated carefully with cotton rolls and thoroughly dried and ozonated water will be applied carefully subgingivally with the help of a disposable 2ml plastic syringe and a 28-gauge needle. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients motivated to have the therapy and complete follow up.
2. Subjects who readily give informed consent for the study.
3. Patients with a minimum number of 15 teeth.
4. Good physical and systemic health.
5. Patients with clinical attachment loss more than or equal to 1 mm .
6. Chronic generalized periodontitis with at least 2-3 sites exhibiting periodontal pockets with depths more than or equal to 4mm will be selected for the study. |
|
| ExclusionCriteria |
| Details |
1. Patients who have undergone periodontal therapy in last 6 months.
2. Patients who had received antibiotic therapy during the previous three months.
3. Individuals who are expecting or who have allergies to the drugs in study.
4. Pregnant ladies and lactating mothers .
5. Regular users of mouthwash.
6. Chronic alcoholics. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Probing Pocket Depth Reduction |
baseline, post-operatively 1 month, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical Attachment Level Gain |
baseline, post-operatively 1 month, 3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Most cases of slight and moderate chronic periodontitis can be successfully managed by mechanical removal and/or reduction of subgingival bacterial biofilms and calculus. The most popular and clinically established periodontal
therapy is scaling and root planing (SRP). However, there are several drawbacks
to SRP. Ozone, is a naturally occurring molecule made up of three oxygen atoms. Because of its great
antibacterial activity without causing medication resistance, ozone is
presently being considered as a potential substitute antiseptic agent in
dentistry Ozone treatment may be administered in a variety
of ways, the most popular being gas and aqueous - Ozonated water and Ozonated Olive Oil. Therefore, the current study aims to assess and compare the efficacy of ozonated water and ozonated olive oil as supplemental to non-surgical treatments for chronic periodontitis. A total of 30 systemically healthy patients with chronic periodontitis will be treated with ozonated water (Group-A) and ozonated olive oil (Group-B). Assessments of clinical parameters will be done at baseline, 1 months and 3 months. Statistical analysis will be performed on the resulting data. |